Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

NCT05188326 | Completed Phase 3

• 1 other identifier: QOLESS-AZA-AMLE
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 18

Brief Summary

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia,; Post-Remission Therapy

Outcome Measures

Primary Outcomes (1)

• Disease free Survival (DFS)

  Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact.

  5 years

Secondary Outcomes (2)

• Hospitalizations

  5 years

• Overall Survival (OS)

  2 and 5 years

Study Arms (2)

Azacitidine

EXPERIMENTAL

Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months

Drug: Vidaza 100 milligram (mg) injection

Best supportive care

PLACEBO COMPARATOR

No drug administration

Other: Best Supportive Care

Interventions

Vidaza 100 milligram (mg) injection DRUG

1st cycle 50 mg/sqm s.c. or i.v. for 7 days (5 + weekend off + 2) every 28 days and increase dosing after 1st cycle, if well tolerated, to 75 mg/ m2 for further 5 cycles, followed by cycles every 56 days for 4 years and six months post-remission.

Also known as: Vidaza

Azacitidine

Best Supportive Care OTHER

Best supportive care includes antibiotics, transfusions and fluids

Best supportive care

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 61 years or more
• Newly diagnosed AML with \> 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
• Absence of central nervous system involvement
• No contraindications for intensive chemotherapy, defined as:
• prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
• a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
• a Performance Status (PS) score of \> 2;
• uncontrolled severe infection.
• Informed consent.

You may not qualify if:

• Age ≤ 60 years
• Newly diagnosed AML with \< 30% myeloid marrow blasts
• Previously treated AML
• Central nervous system involvement
• Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
• A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
• A PS score of \> 2;
• Uncontrolled severe infection.

Sponsors & Collaborators

• Associazione Qol-one: lead

Study Sites (18)

A.O. SS. Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Location

Ospedale Riuniti

Ancona, AN, Italy

Location

A.O. S. Giovanni Moscati

Avellino, AV, Italy

Location

Policlinico Università di Bari

Bari, BA, Italy

Location

Ospedale L'Annunziata

Cosenza, CS, Italy

Location

Ospedale Ferrarotto

Catania, CT, Italy

Location

Ospedale Garibaldi

Catania, CT, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, Italy

Location

Università degli Studi di Genova

Genova, GE, Italy

Location

IRCCS Ospedale Maggiore Policlinico

Milan, MI, Italy

Location

Ospedale Civile Spirito Santo

Pescara, PE, Italy

Location

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Reggio Calabria, RC, 89100, Italy

Location

Ospedale Sant'Eugenio

Roma, RM, Italy

Location

Policlinico Agostino Gemelli

Roma, RM, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, RM, Italy

Location

IRCCS Istituto Regina Elena

Rome, RM, Italy

Location

A.O.U. San Giovanni di Dio e Ruggì D'Aragona

Salerno, SA, Italy

Location

A.O.U. di Udine Centro Trapianti e Terapie Cellulari

Udine, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Injections; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Esther Natalie Oliva

  QOL-ONE Associazione Culturale e di Ricerca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: November 28, 2010
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (18)